Placebo devices as effective control methods in acupuncture clinical trials : a systematic review

While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility

Evaluation of three standardised placebo acupuncture devices : a systematic review

This review suggested that none of these three devices can be used as a perfect placebo; an improved placebo device is needed for future investigation of acupuncture efficacy

Light in the Darkness: Accessibility to Palliative Care for Cancer Patients of Chinese Background and Their Families

Background: Palliative care (PC) improves the Quality of Life (QoL) of patients and their families facing life-threatening illness, through the provision of physical, psychosocial and spiritual support. Cancer is the most frequently recorded principal diagnosis for PC-related services. However, studies have found that people from culturally and linguistically diverse communities face unique challenges when trying to access PC. Chinese Australians, a large non-English speaking ethnic minority in Australia, remain under-represented in PC service delivery. Aim and Objectives: This project aims to address the barriers that prevent Chinese Australians from receiving and benefiting from PC, through the perspective of cultural and linguistic issues. Methodology: The project comprises a general survey of Chinese Australian cancer patients and their caregivers, as well as in-depth one-to-one interviews. Information sessions on PC were conducted in four Sydney suburbs. The questionnaires were distributed and collected before the sessions. The Survey sought to assess participants’ knowledge and level of understanding about PC, and the difficulties they face when trying to access the services available to them

Examination of needle surface corrosion in electroacupuncture

Background: Electroacupuncture (EA) is a modern form of acupuncture therapy where stainless steel acupuncture needles are used as percutaneous electrodes to apply electrical stimulation. The concern about electrolytic corrosion of needles during EA has not been conclusively addressed. Aim: To examine whether corrosion of stainless steel acupuncture needles occurs after EA to establish the safety profile of this therapy. Methods: The study comprised four EA sessions on healthy participants mimicking a common clinical practice, with needle surface examinations conducted immediately after each session. Used acupuncture needles that did not undergo electrical stimulation and unused needles taken from the original package were also examined as control comparisons. Two commonly used types of single-use, silicone-coated, stainless steel needles were selected for the experiment. The ES-160 digital acupunctoscope (a charge-balanced electric stimulator) was used to deliver electrical stimulation, and an oscilloscope was used to record the waveforms and electric currents. All needles were sterilised before examination by a scanning electron microscope (SEM), where images of needle tips and shafts were taken for further analysis. Results and conclusions: 32 needles were examined under the SEM. As the main findings, the SEM images showed the surface finish, burr attachments and surface characteristics of needle samples. No evidence of electrolytic corrosion was detected on any needle that underwent electrical stimulation for 30 min delivered by a charge-balanced acupunctoscope in healthy participants. The choice of a charge-balanced acupunctoscope is recommended to avoid any potential corrosion of needles in EA clinical practice

Placebo devices as effective control methods in acupuncture clinical trials : a systematic review

Acupuncture has been widely used to treat certain conditions in clinical practice. However, clinical trials with control groups have yielded conflicting results. There is a need for rigorous studies to evaluate the efficacy of acupuncture over placebo. Three placebo acupuncture devices have been designed including the Streitberger Device, the Park Device and the Takakura Device. They have been validated and widely used in RCTs. The authors of this systematic review aimed to examine whether these three devices fulfil the requirements of being an ideal placebo. Two major requirements of placebo (maximised blinding and minimised treatment effects) were taken into consideration in this research

Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

<div><p>While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility.</p></div

Acupuncture for polycystic ovarian syndrome

Background: PCOS is where women have multiple cysts (fluid-filled sacs) on their ovaries (organs that produce eggs) and is characterised by the clinical signs of infrequent or very light menstruation (periods), failure to conceive (become pregnant) and excessive hair growth. Women may or may not have symptoms. The current standard western treatments for women with PCOS are prescription medicines, surgery and lifestyle changes. There has been evidence suggesting acupuncture may influence ovulation (release of the egg) by affecting levels of various hormones. Acupuncture is a Chinese therapy where fine needles are inserted into the skin in certain places. The exact mechanism of how acupuncture works for PCOS is not known and we aimed to explore the use of it for PCOS in this review. Study characteristics: We searchedmedical databases for clinical studies where people were randomly put into one of two or more treatment groups including acupuncture treatment for women with PCOS who were infrequently or never ovulating. Acupuncture was compared with pretend acupuncture (sham), no treatment, lifestyle changes (e.g. relaxation) and conventional treatment. We included eight studies with 1546 women in this review. The studies compared true acupuncture versus sham acupuncture, clomiphene (medicines to induce ovulation), relaxation and Diane-35 (combined oral contraceptive pill); and low-frequency electroacupuncture (where small electrical currents are passed through the acupuncture needles) versus physical exercise. We included women who wanted to get pregnant and women who wanted regular ovulation and symptom control as our two main populations of interest. Key results: Ourmain interests were live birth rate,multiple pregnancy rate (for women who wanted to get pregnant) and ovulation rate (for women who wanted regular ovulation/symptom control). Due to the very low quality of the evidence and imprecise results, we were uncertain of the effect of acupuncture on live birth rate, multiple pregnancy rate and ovulation rate compared to sham acupuncture. For the same reasons, we were also uncertain of the effect of acupuncture on clinical pregnancy and miscarriage rate. Acupuncture may have improved restoration of regular menstrual periods. Acupuncture probably worsened side effects when compared to sham acupuncture. No studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as women were only interested in symptom control. We were uncertain whether acupuncture improved ovulation rate compared to relaxation or Diane-35 (measured by ultrasound, which uses high-frequency sound waves to create an image, threemonths after treatment). The other comparisons did not report on ovulation rate. Side effects were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane- 35. These included dizziness, nausea (feeling sick) and bruising. The overall evidence was low or very low quality. There is currently insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS. Quality of the evidence: The evidence ranged from very low to moderate quality, the main limitations were not reporting important clinical results and not enough data

Systematic review of acupuncture placebo devices with a focus on the credibility of blinding of healthy participants and/or acupuncturists

Background: An ideal placebo design in clinical research should resemble the intervention under investigation to facilitate blinding, yet remain clinically inert. With regard to physical interventions such as acupuncture, a true placebo device has not been developed and validated. Since 1998, researchers have designed several placebo acupuncture devices (PADs). The three most widely used PADs are the Streitberger, the Park and the Takakura device. Aim: This review focuses on evaluating studies of these devices, in the context of credibility of blinding (COB), assessment of penetrating pain or sensation, and de qi sensation. Methods: Electronic database searches were conducted in four English and two Chinese databases from their inception until November 2016. All studies included in the review were conducted on healthy participants and compared verum manual acupuncture with any of the aforementioned PADs with respect to one or more of the above three outcomes related to blinding effect. Results: The synthesised analyses of the 15 included studies showed that the Streitberger and Park placebo devices may not blind participants successfully when tested at a sensitive acupuncture point (LI4). In terms of penetrating sensation, there were significant differences between these two placebo devices and verum acupuncture when applied at this point. The Takakura device was the only PAD that had the potential to blind the acupuncturist. However, the blinding analyses of all outcome measures were inconsistent. Conclusion: Overall, there were insufficient data to confirm the blinding effects of these skin-contact PADs as each device was associated with limitations that warrant further design improvements

PRISMA flow diagram of study selection process.

<p>PRISMA flow diagram of study selection process.</p

Treatment effects of meta-analysis results.

<p>Treatment effects of meta-analysis results.</p